NAC long

Acetylcysteine.

White, flat, round tablets, breaking notch on one side, characteristical odor of acetylcysteine and lemon aroma.
Each NAC LONG effervescent tablet contains acetylcysteine 600 mg.
Excipients with known effect: Each NAC LONG effervescent tablet contains 20.0 mg aspartame.
Each NAC LONG effervescent tablet contains 145 mg sodium (as sodium hydrogen carbonate).
Excipients/Inactive Ingredients: Sodium hydrogen carbonate, Citric acid anhydrous, Aspartame, Lemon aroma, Water purified.

Pharmacotherapeutic group: Cough and cold preparations, expectorants, excl. combinations with cough suppressants, mucolytics. ATC code: R05CB01.
Pharmacology: Pharmacodynamics: Mechanism of action and pharmacodynamic effects: Acetylcysteine is a mucolytic agent that reduces the viscosity of purulent and nonpurulent pulmonary secretions and facilitates their removal by coughing, postural drainage, or mechanical means. Acetylcysteine exerts mucolytic action through its free sulfhydryl group which opens up the disulfide bonds in the mucoproteins thus lowering mucous viscosity.
Pharmacokinetics: Absorption and distribution: Following oral administration, acetylcysteine is rapidly absorbed from the gastrointestinal tract and peak plasma concentrations occur about 0.5 to 1 hour. Due to the high first pass effect, the bioavailability of orally administered acetylcysteine is very low and mean values have ranged from 4 to 10%. The volume of distribution of total acetylcysteine was reported to range between 0.33 and 0.47 L/kg. Protein binding of acetylcysteine is about 50%.
Biotransformation: Acetylcysteine is mainly deacetylated to cysteine in the liver. Most of this is processed in the amino acid metabolism. Moreover, it forms reversible disulfide compounds with amino acids and proteins with free sulfhydryl groups.
Elimination: Renal clearance may account for about 30% of total body clearance, which was 0.211 L/h/kg.
The terminal half-life of total acetylcysteine was 6.25 hours after oral doses.

Adults: All diseases of the respiratory tract connected to mucous secretion.
Adjunctive mucolytic therapy in patients with abnormal or viscid mucous secretions in such conditions as: Chronic bronchopulmonary diseases e.g., chronic emphysema, chronic asthmatic bronchitis, tuberculosis, bronchiectasis, primary amyloidosis of the lung; Acute bronchopulmonary disease e.g., pneumonia, bronchitis, tracheobronchitis.
Children aged 6 years and older: Reduction of sputum viscosity.

Adults and children aged 6 years and older: Unless otherwise directed, the recommended dose is to take 1 effervescent tablet daily.
The duration of the treatment is depending on the clinical picture. In case of chronic diseases NAC LONG is applied over longer periods of time or in treatment cycles of several months.
The effervescent tablet should be taken dissolved in half a glass of water and should be administered before or after the meals.
For patients with a reduced cough reflex (elderly and weakened patients) are advised to take the acetylcysteine effervescent tablet in the mornings.

No toxic overdose has yet been observed with oral pharmaceutical forms of acetylcysteine.
Voluntary study subjects were treated for three months with a dose of 11.6 g acetylcysteine per day without any serious undesirable effects being observed. Oral doses of up to 500 mg acetylcysteine per kg body weight were tolerated without any signs of poisoning.
Symptoms: Overdoses may lead to gastrointestinal effects such as nausea, vomiting and diarrhoea.
Management: Symptomatic treatment if necessary.

Hypersensitivity to the active substance or to any of the excipients listed in Description.

In case of phenylketonuria (a hereditary metabolic disease) it must be observed that this drug contains an amount of the sweetener Aspartame corresponding to 11.22 mg phenylalanine.
Effervescent tablets contain sodium; consider acetylcysteine treatment as a source of sodium in patients who may be sensitive to excess sodium intake.
Serious skin reactions such as Stevens-Johnson syndrome and Lyell's syndrome have very rarely been reported in temporal connection with the use of acetylcysteine. In most cases, at least one other suspect medicinal product, which was more likely the cause of the mucocutaneous syndrome could be identified. If cutaneous or mucosal alterations newly occur, immediate medical advice should be sought and the treatment with acetylcysteine should be discontinued immediately.

Pregnancy: Although there are no known indications of any particular teratogenic risk, acetylcysteine should be taken during pregnancy only on the doctor or pharmacist's express advice.
Lactation: Since it is not known if acetylcysteine is distributed into human milk, the drug should be used with caution in nursing women.

Undesirable effects observed in temporal connection with the application of acetylcysteine but not in every patient. The following table shows undesirable effects after oral use of acetylcysteine according to system organ class (SOC). (See table.)

Click on icon to see table/diagram/image

The effect of some drugs may be influenced by contemporaneous application of other drugs. Therefore ask the doctor if the patient uses other drugs permanently, if the patient has used them recently or if the patient has to use them contemporaneously with the present drug. The physician is able to let the patient know whether the patient has to expect interactions under these circumstances or whether special measures e.g., a new dosage is necessary, in case the patient uses this drug.
Tetracycline hydrochloride should be administered separately and at least 2 hours apart (not valid for Doxycycline).
Antitussive agents should not be given concomitantly with acetylcysteine, because a decrease in the cough reflex may result in the accumulation of bronchial secretions.
The concomitant administration of acetylcysteine and nitroglycerin should be avoided because it induces hypotension. If concomitant administration cannot be avoided, patients should be monitored for hypotension and warned about the possible occurrence of hypotension and headache.

Store in original packaging to protect the contents from light and moisture.
Re-seal tubes immediately after removing tablets.
Do not store beyond 25°C.
The drug should not be used after the expiration date.

Cough & Cold Preparations / Antidotes & Detoxifying Agents

R05CB01 - acetylcysteine ; Belongs to the class of mucolytics. Used in the treatment of wet cough.

NDD